Efficacy of Artemether-Lumefantrine and Amodiaquine-Artesunate for treatment of Uncomplicated Malaria in Children in Uganda

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000408785

Enrollment

600

Registered

2013-04-15

Start date

2013-04-25

Completion date

2014-05-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To estimate the clinical and parasitological efficacy of two artemisinin-based combination therapies (artemether-lumefantrine and artesunate-amodiaquine) included in the national policy for the treatment of uncomplicated falciparum malaria in children. The study will be conducted in three Uganda Malaria Surveillance Project sentinel sites. The results will be used to formulate recommendations enabling the Ministy of Health to make decisions about the possible need for updating the current national antimalarial treatment policy.

Interventions

artemether-lumefantrine in fixed combination tablet each containing 20 mg of artemethr and 120 mg lumefantrine. Tablets will be given twice daily for three consecutive days. The number of tablets per dose is according to body weight. Children between 5 and 14 kg body weight will receive 1 tablet, between 15 and 24 kg, two tablets, between 25 and 34 kg, 3 tablets, and over 35 kg 4 tablets per dose. This dosing regimen is as per natioanl policy for this indication.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

6 Months to 59 Months

Healthy volunteers

Inclusion criteria

Age 6-59 months Uncomplicated malaria due to P. falciparum mono-infection with parasite density between 2000 and 200,000 /microliter of blood Fever ( > 37.5 degrees Celsius axillary) or history of fever in the previous 24 hours Provision of informed consent and ability to participate in 28-day follow-up (patient has easy access to health unit) Not previously enrolled in this study

Exclusion criteria

Weight less than 5 kg History of serius side effects to study medications Concomitnt febrile illness in addition to malaria Danger and signs or evidence of severe malaria Severe malnutiriton Regular medication which may interfere with the antimalarial pharmacokinetic History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested.

Outcome results